Endoscopic procedures for treating abnormal pathologies within the alimentary canal system and biliary tree (including the biliary, hepatic, and pancreatic ducts) are increasing in number. The endoscope provides access to the general area of a desired duct using direct visualization. However, the duct itself must be navigated using a catheter and guidewire in conjunction with fluoroscopy.
Catheters are generally known for treatment of targeted anatomical regions. For example, known biliary catheters and methods of use are disclosed in U.S. Pat. No. 5,397,302 to Weaver et al., and U.S. Pat. No. 5,320,602 to Karpiel, the disclosures of which are incorporated herein by reference. In general, for treatment of an abnormal pathology within a patient's biliary tree, an endoscope is first introduced into the mouth of the patient. The endoscope has a proximal end and a distal end, and includes a lumen extending longitudinally between the proximal and distal ends. The endoscope is guided through the patient's alimentary tract or canal until an opening at the distal end of the endoscope is proximate the area to receive treatment. At this point, the endoscope allows other components, such as a catheter, to access the targeted area.
For visualization and/or treatment within the biliary tree, the distal end of the endoscope is positioned proximate the papilla of vater leading to the common bile duct and the pancreatic duct. A catheter is guided through the lumen of the endoscope until a distal tip of the catheter emerges from the opening at the distal end of the endoscope. A guidewire may be used in conjunction with the catheter to facilitate accessing a desired location within the biliary tree. The guidewire is inserted into an opening at a proximal end of the catheter and guided through the catheter until it emerges from the distal end of the catheter. The catheter and guidewire are used to further access the biliary tree. The distal ends of the catheter and guidewire are guided through the orifice to the papilla of vater (located between the sphincter of oddi) leading to the common bile duct and the pancreatic duct.
For visualization and/or treatment of the common bile duct, the guidewire is guided into the common bile duct. The catheter is advanced over the guidewire or the catheter and guidewire are advanced together until the distal end of the catheter is positioned in the common bile duct at the desired location. The catheter is now in position for delivery of therapeutic agents or contrast media for fluoroscopic visualization of anatomical detail. Once the catheter and guidewire are in place relative to the targeted area, it is highly desirable to maintain position of the guidewire during subsequent catheter procedures, including catheter exchange procedures, so that re-navigating to the target site is unnecessary.
Present biliary endoscopic procedures utilize multi-lumen catheters for endoscopic retrograde cholangiopancreatography and endoscopic retrograde sphincterotomy, utilize balloon catheters for retrieval and stent delivery, and utilize other therapeutic and diagnostic devices. Conventional devices such as catheters used in these procedures are at least 200 cm long since they must pass through the endoscope, which is commonly at least 150 cm long. As described in general above, biliary endoscopic procedures are performed using a guidewire. Therefore, when using a standard catheter having a guidewire lumen extending the full length of the catheter, the guidewire must be at least 450 cm long to accommodate the exchange of different devices while maintaining access and position within the biliary tree. The exchange of devices over a 450 cm guidewire is both time consuming and cumbersome.
Due to the length of the guidewire, physicians require at least two assistants in the room to perform the procedure. Typically, one assistant is responsible for the patient and device-related concerns, while the other assistant is responsible for the guidewire. The additional hands required due to the length of the guidewire results in a relatively more time consuming and costly procedure.
To address these issues, single operator exchange catheters (also referred to as rapid exchange catheters) have been developed. An example a of single operator exchange catheter is disclosed in U.S. Pat. No. 6,007,522, issued on Dec. 28, 1999, entitled “Single Operator Exchange Biliary Catheter”, the entire disclosure of which is incorporated herein by reference. Such single operator exchange catheters are adapted for use within the alimentary canal and have features which facilitate rapid exchange and allow an exchange procedure to be performed by a single operator. Specifically, single operator exchange catheters may be used in connection with a conventional length guidewire, and thus are easier to use and require less personnel for performing biliary procedures.
Single operator exchange catheters have a relatively short distal guidewire lumen extending between a distal guidewire port disposed adjacent the distal end of the catheter and a proximal guidewire port disposed distal of the proximal end of the catheter and proximal of the distal end of the catheter. The guidewire extends through the guidewire lumen between the proximal and distal guidewire ports.